Youth Functioning and Organizational Success for West African Regional Development: Scale Up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,783
- 试验地点
- 3
- 主要终点
- Costing Analysis
研究概览
简要总结
Objectives:
The objectives of this research proposal are to study the delivery of an evidence-based mental health intervention in the alternate setting of youth employment programs tied to regional economic development and to examine the use of a Collaborative Team Approach (CTA) as an implementation scale-up strategy that addresses the human resource shortage and related access to care and capacity challenges in low- and middle-income countries (LMICs). Specifically, this study aims to examine the incorporation of the evidence-based Youth Readiness Intervention (YRI) into a program that promotes employment among youth (EPP/Entrepreneurship Training program) through a pilot study and scale-up intervention study in Sierra Leone.
Study population:
The study population includes youth, ages 18-30, with elevated t-scores on assessments of functional impairment and emotional dysregulation, who live in the Kono, Koinadugu and Kailhun districts of Sierra Leone.
Scale-up study design:
For the scale-up study, a Hybrid Type 2 Effectiveness-Implementation Cluster Randomized Three-arm trial will be employed. We estimate the entire sample size for the scale-up study to be 3,630 participants, including 1200 youth, 10 agency heads, 20 intervention facilitators, and 2400 third-party informants. Upon enrollment into the study, youth will be assigned to community level sites based on geographical location. Each of these community level sites will make up one cluster. These clusters will be randomized into the three study conditions: the control condition - where youth do not receive the YRI or the EPP but are able to utilize as available resources in the community - the EPP-only condition, and the YRI+EPP condition. Data will be collected at baseline, post-YRI, post-EPP, and 12-months follow-up.
Scale-up study outcomes:
Implementation outcomes of the Hybrid Type II study are focused on process and implementation aspects including a costing analysis, measures of fidelity and the sustainment and quality of delivering YRI within a Collaborative Team Approach to support intervention delivery, training and supervision. Effectiveness outcomes of the Hybrid Type II study are development of emotion regulation, mental health assessed as anxiety and depression, and interpersonal functioning, including self report and by third-party reporters for assessment of the YRI's ability to improve youth's interpersonal skills and functioning in the community and the entrepreneurship training program. In a Hybrid Type II study implementation and effectiveness aims are dual and equally important aspects of the study. (Curran et al., 2015) Outcomes associated with both aims are considered primary outcomes in this study.
详细描述
Scale-up Study Objectives
We propose to implement and test an evidence-based intervention called the Youth Readiness Intervention (YRI) alongside GIZ's youth entrepreneurship training (EPP). This scale-up study expects to enroll 1200 youth across three treatment arms (control, EPP, YRI+EPP) across GIZ's three target districts. Typically, GIZ targets youth considered to be underemployed or unemployed and youth with low literacy levels. While that criteria will remain, given the socioemotional aims of the YRI, youth must also demonstrate impaired functioning and emotional dysregulation as assessed by a screening tool (see section 4b for more information regarding inclusion criteria). Together, this model is intended to improve the mental health and functioning of vulnerable Sierra Leonean youth while demonstrating the capacity for a technical behavioral change intervention to be delivered via an alternative delivery platform like employment programs. Past implementation of the YRI in Sierra Leone has led to the creation of an evidence-informed intervention that is both relevant and culturally responsive. Most importantly, however, the previous implementation of the YRI RCT within education relied on trained counselors. By demonstrating that the YRI can be delivered by service professionals who may not have clinical training while integrated into employment programming the ability for Youth FORWARD to be adopted for scale-up across Sierra Leone and other LMICs is further strengthened. Specifically, the objects and aims of this scale up study are:
AIM 1 (Implementation Impact Evaluation): To utilize an innovative Collaborative Team Approach (CTA) to scaling and sustaining the YRI in terms of feasibility of this approach, facilitator preparedness and sense of satisfaction and impacts on fidelity and sustainment of delivery of YRI.
AIM 2 (Implementation Process Evaluation): To identify internal and external factors influencing the integration of the YRI into the youth EPP programs via a process evaluation documenting barriers and facilitators to effective implementation and integration.
AIM 3 (Clinical Effectiveness): To compare clinical effectiveness of YRI when delivered via the EPP platform to results of our previous randomized control trial (RCT) of YRI as measured by improved mental health and reduced functional impairments among high-risk youth. Emotion regulation will be examined as a major mechanism by which the YRI improves behavior of treated youth and their functioning in the EPP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Under the supervision of Innovations for Poverty Action (IPA) Sierra Leone, local research assistants (blind to site and youth condition assignments) will conduct all screening, baseline, and follow up quantitative assessments. Ongoing data collection at all sites will include youth attendance and satisfaction with YRI content, counselor satisfaction with content and delivery via scales and qualitative exit interviews, as well as monitored audio-recording of all sessions for fidelity by an independent expert rater hired by CARITAS. The expert fidelity monitor will be a skilled YRI trainer and supervisor from our prior RCT and will not be a part of the CTA Seed Team, thus allowing them to provide impartial and blinded fidelity ratings of all audio-transcripts.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Youth aged 18-30 will be included in the Youth FORWARD scale-up study based upon eligibility to the employment program, focusing specifically on socioeconomic status and willingness and interest in participation in an employment program, as well as mental health screening, which will include questions on daily functioning and emotional regulation.
- •Specifically, inclusion criteria for the youth sample is:
- •be Sierra Leonean,
- •be female or male aged 18-26,
- •be considered a vulnerable youth who is disengaged from both education and employment programs,
- •have elevated t-scores on functional impairment based on thresholds from our previous research using questions adapted from the World Health Organization Disability Assessment Schedule (WHODAS)54 and,
- •have elevated t-scores (62.5 or above) on the Disturbances in Emotion Regulation Scale (DERS).55
- •Inclusion criteria for agencies in this study is:
- •be a "service provision agency" in Sierra Leone,
- •have a minimum of two experts employed, one with subject-specific knowledge and; experience, and another with pedagogical experience in adult education and working with youth with low literacy, and
- •sign a Memorandum Of Understanding (MOU) with Boston College (BC) regarding intellectual property of the YRI.
- •Inclusion criteria for facilitators in this study is:
- •be employed by one of the agencies selected in GIZ's competitive bidding process, and
- •agree to participation in the ICTA which utilizes an enhanced supervision structure throughout the intervention.
- •Inclusion criteria for third-party reporters in this study is:
- •be over age 18,
- •be nominated by the youth participant,
- •provide oral consent to participate in the quantitative assessments, and
- •have daily to weekly contact with the youth participant throughout the duration of this scale-up study, which will be assess via verbal confirmation when obtaining oral consent.
- •Inclusion criteria for agency leaders is:
- •must be a part of one of the agencies selected in GIZ's competitive bidding process and,
- •must hold a leadership position in the agency.
排除标准
- •Exclusion criteria for the youth:
- •Youth will be excluded from the study if they do not fulfill the inclusion criteria or:
- •present with severe mental illness (e.g., psychosis), or
- •developmental disability that precludes comprehension of the intervention content and assessments.
- •Specifically, mental health exclusion criteria are:
- •severe, active suicidality or psychosis as assessed via the MINI-KID diagnostic assessment administered by a study social worker and,
- •serious cognitive impairments that might preclude one's ability to comprehend informed consent and complete study assessments as determined by a study social worker.
- •Youth who report active suicidality or symptoms of psychosis requiring more intensive mental health care will be referred for immediate individual mental health services
- •Exclusion criteria for the agencies:
- •Agencies will be excluded from participation if:
- •they are not considered a "service provision agency", and
- •if they do not have a minimum of two experts employed: one with subject-specific knowledge and experience, and another with pedagogical experience in adult education and working with youth with low literacy.
- •Those holding leadership positions within the agencies selected to deliver the intervention will be excluded from participation in the qualitative interviews if:
- •they are not employed at the agencies selected, or
- •are not considered to be in a leadership position within the agency.
- •Exclusion criteria for the facilitators:
- •Facilitators will be excluded from participation in delivering the intervention if:
- •they are unable to deliver core components of the YRI and EPP intervention, and
- •if they are unable to meet the logistical demands of the ICTA
- •Exclusion criteria for the third-party reporters:
- •The third-party reporter will be excluded from the study if:
- •they are under age 18,
- •present with severe mental illness (e.g., psychosis), or
- •developmental disability that precludes comprehension of the intervention content and assessments (as determined by a study social worker), and
- •if the third-party reporter does not have at least monthly contact with the youth participant
结局指标
主要结局
Costing Analysis
时间窗: 12 months
A costing analysis will be conducted to determine the financial feasibility of the YRI. We will conduct a return on investment (ROI) analysis. The main categories of cost to be quantified are: * Salaries/wages of staff involved in the scale-up study (e.g. salaries of agency staff)-including supplementary benefits, allowances, and employer contributions to local/national taxes or health insurance plans * Facility operating costs associated with running the establishments involved in the scale-up study (e.g. EPP training centers) * Overhead and capital costs relating to the intervention Cost estimates will be obtained from various sources, such as invoices, quotes, employee and contracts. For costs that are difficult to determine with accuracy, we will use estimates by consulting sources to provide effectiveness estimates of the YRI and cost per participant and cost-per-outcome.
Facilitator-level outcome measures
时间窗: 3 months and 12 months
At the facilitator level we are most interested in assessing one's experience delivering the intervention, including information regarding fidelity, feasibility, and acceptability. These measures include: * Seed Team Assessment Battery, sum scores, higher scores denote higher levels of collaboration and cohesion * Evidence-based Practice Attitudes Scale (adapted) * Levels of Collaboration Scale (adapted) * Team Assessment Questionnaire (adapted) * Perceived Cohesion Scale (adapted) * Facilitator Qualitative Interview Guide
Implementation science measures
时间窗: baseline and 3 months
* YRI Fidelity Checklist * Dissemination and Implementation Facilitator Survey, higher scores denote higher elements of dissemination and implementation * Dissemination and Implementation Agency Survey, see above for scoring * Dissemination and Implementation Participant Survey, see above for scoring
Difficulties in Emotion Regulation
时间窗: baseline, 5-weeks, 3-months and 12-months follow-up
Changes in youth emotion regulation will be assessed via: • Difficulties in Emotion Regulation (DERS), clinical cut point of 62.5, higher scores denote higher emotion dysregulation
Oxford Measure of Psychosocial Adjustment
时间窗: baseline, 5-weeks, 3-months and 12-months follow-up
Changes in youth psychosocial adjustment will be assessed via the Oxford Measure of Psychosocial Adjustment which assesses mental health, prosocial attitudes, and functioning. Higher scores on this measure indicate worse psychosocial adjustment.
Hopkins Symptom Checklist
时间窗: baseline, 5-weeks, 3-months and 12-months follow-up
Changes in youth mental health will be assessed via the Hopkins Symptom Checklist which assesses anxiety and depression. Higher scores on this measure indicate worse mental health.
WHO Disability Assessment Schedule
时间窗: baseline, 5-weeks, 3-months and 12-months follow-up
Changes in youth functioning will be assessed via: the WHO Disability Assessment Schedule, there is no cut point for this measure but higher scores indicted greater functional impairment.
Economic Self Sufficiency
时间窗: baseline, 5-weeks, 3-months and 12-months follow-up
Youth economic self sufficiency will be assessed using a template that captures employment across different employment sectors, income generated, and hours worked. This template looks at change over time.
次要结局
未报告次要终点